BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    QuickSleeper 5

    K Number: K243427 · Decision Aug 1, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    269

    Basic Information

    Device Name
    QuickSleeper 5
    K Number
    K243427
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4475
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dentalhitec
    Date Received
    November 5, 2024
    Decision Date
    August 1, 2025
    Product Code
    EGM
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EGM Injector, Jet, Mechanical-Powered

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